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It was a day of positive developments for the Hyderabad-based Natco Pharma.
First, the company and its partner Alvogen settled a patent infringement suit related to the generic versions of Tamiflu, oral capsules (Oseltamivir phosphate), 30 mg, 45 mg and 75 mg.
The suit was filed in the New Jersey District Court Against Natco and Alvogen by Gilead Sciences, Ind., Hoffmann La Roche, Inc and F Hoffmann-La Roche Ltd and Genentech.
As per the terms of settlement, Natco’s partner Alvogen will be able to market the capsules before the expiration of the paediatric exclusivity period listed in FDA’s Orange Book for US Patent No 5,763,483, which is February 23, 2017.
The second development is the granting of approval from the Drugs Controller General of India (DCGI) to market the generic version of Daclatasvir, a drug used for treatment of chronic hepatitis C.
Natco Pharma has in a filing with the BSE said it is the first company in India to get approval for generic Daclatasvir Dihydrochloride (Daclatasvir) tablets, 30 mg & 60 mg, from the Drugs Controller General (India).
Infringement case:
Natco Pharma Ltd and Alvogen in a collaborative effort developed and filed the first Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration, for the generic versions of Tamiflu.
The USFDA had granted tentative approval for the generic oseltamivir phosphate capsules on March 14, 2014.
Hepatitis C drug:
According to a Natco press release, Daclatasvir is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection.
The company said it will market the generic Daclatasvir under its brand ‘NATDAC’, and through its strategic partners in India. It will launch immediately in the country at Rs 6,000 and Rs 4,000 for the 60 mg and 30 mg dosages, respectively, for a bottle of 28 tablets.
Compared with other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult—to—treat HCV patient subsets, the release stated.
Shares of Natco closed at Rs 549.25, up 3.20 per cent over its previous close on BSE.
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